Published FDA guidelines* identify seven (7) entrapment zones as posing a possible risk of patient injury. The FDA has established a measuring protocol and pass/fail criteria for zones 1 through 4 in their guidelines. As of the date of this publication, the FDA has yet to publish pass/fail criteria for zones 5 through 7.
* FDA Docket No. 2004D-0343, March 10, 2006.
Posey product solutions can help mitigate FDA patient entrapment concerns!
Zone #1:
Entrapment risk area – Within the Side Rail
· Side Rail Wedges
· Side Rail Covers
· Split Side Rail Protectors
· Seizure Pads
Zone #2:
Entrapment risk area – Under the Rail, Between the Side Rail Supports or Next to a Single Rail Support
· Side Rail Wedges
· Gap Fillers
· Deluxe Guard Rail Pads
· Bed Bumpers
Zone #3:
Entrapment risk area – Between the Side Rail and the Mattress
· Side Rail Wedges
· Gap Fillers
· Bed Bumpers
Zone #4:
Entrapment risk area – Under the Rail at the End of the Side Rail
· Side Rail Wedges
· Horseshoe Wedges
· Gap Protectors
Zone #5:
Entrapment risk area – Entrapment Between Split Bed Rails
· Gap Protectors
· Deluxe Guard Rail Pads
· Split Side Rail Protectors
Zone #6:
Entrapment risk area – Entrapment Between the End of the Rail and the Side Edge of the Head or Footboard
· Side Rail Wedges
· Gap Fillers
· Horseshoe Wedges
· Bed Bumpers
Zone #7:
Entrapment risk area – Entrapment Between the Head or Footboard and the Mattress End
· Gap Fillers
· Bed Bumpers
· Horseshoe Wedges
Posey recommends the use of HBSW compliant side rails in the “Up” position with gaps filled whenever patient restraints are used.